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Platelets Antiaggregation Control Enhancement (PACE) Study (PACE)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2013 by Luca Weltert, Cardiochirurgia E.H..
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01218074
First Posted: October 11, 2010
Last Update Posted: February 15, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Luca Weltert, Cardiochirurgia E.H.
  Purpose
Many patients undergo cardiac surgery without proper suspension of antiaggregation drugs. This is blamed to increase dramatically bleeding and use of allogenic blood transfusions. The investigators test the hypothesis that routine use of aggregometry could show antiaggregated patient and lead to normalization of platelet function via administration of Desmopressin thus limiting bleeding and transfusions.

Condition Intervention
Bleeding Blood Transfusion Device: Aggregometry+Thromboelastography Device: Thromboelastography Alone

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Platelets Antiaggregation Control Enhancement Study: an Independent Randomized Blind Prospective Study

Resource links provided by NLM:


Further study details as provided by Luca Weltert, Cardiochirurgia E.H.:

Primary Outcome Measures:
  • Bleeding Volume [ Time Frame: 12 hours after end of operation ]
    Total amount of bleeding in the first 12 hours after cardiac surgery expressed as milliliters of blood in the chest drains reservoir.


Secondary Outcome Measures:
  • Use of allogenic blood transfusions. [ Time Frame: In hospital stay (usually 5 to 8 days after operation) ]
    Number of allogenic blood units transfused per patients during the full hospital stay, usually 5 to 8 days after operation.


Estimated Enrollment: 400
Study Start Date: December 2010
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Thromboelastography alone
Patients undergo standard of care Thromboelastography to evaluate overall coagulation performances.
Device: Thromboelastography Alone
Patients undergo standard of care Thromboelastography to evaluate overall coagulation performance.
Experimental: Aggregometry+Tromboelastography
Patients undergo standard thromboelastography and subsequent aggregometry to test effectiveness of residual antiaggregation drugs. Patients found to have altered value undergo optimization with desmopressin.
Device: Aggregometry+Thromboelastography
Patients undergo standard thromboelastography and subsequent aggregometry to test effectiveness of residual antiaggregation drugs. Patients found to have altered value undergo optimization with desmopressin.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • all patients undergoing surgical myocardial revascularization.

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01218074


Contacts
Contact: Luca P Weltert, MD +393478880617 lweltert@gmail.com
Contact: Saverio Nardella, MD save78@virgilio.it

Locations
Italy
European Hospital Recruiting
Rome, Italy, 00149
Contact: Luca P Weltert, MD    +393478880617    lweltert@gmail.com   
Contact: Saverio Nardella, MD       save78@virgilio.it   
Principal Investigator: Luca P Weltert, MD         
Sponsors and Collaborators
Cardiochirurgia E.H.
  More Information

Responsible Party: Luca Weltert, Project Leader Luca Weltert, Cardiochirurgia E.H.
ClinicalTrials.gov Identifier: NCT01218074     History of Changes
Other Study ID Numbers: 00-04
First Submitted: October 5, 2010
First Posted: October 11, 2010
Last Update Posted: February 15, 2013
Last Verified: February 2013

Keywords provided by Luca Weltert, Cardiochirurgia E.H.:
bleeding
blood sparing procedure
desmopressin
aggregometry
thromboelastography

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes
Deamino Arginine Vasopressin
Hemostatics
Coagulants
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs